-- Peanut Allergy is One of the Most Common
Food Allergies in Europe --
-- Up to 1.6% of European Children Live with
Potentially Life-Threatening Peanut Allergy --
Aimmune Therapeutics, Inc., a Nestlé Health Science Company,
today announced that the European Commission (EC) has approved
PALFORZIA® [defatted powder of Arachis hypogaea L., semen
(peanuts)] for the treatment of peanut allergy. PALFORZIA is
indicated in patients aged 4 to 17 years with a confirmed diagnosis
of peanut allergy in conjunction with a peanut-avoidant diet and
may be continued in patients 18 years of age and older.
“Today’s approval is a historic moment for the millions of
people living with potentially life-threatening peanut allergy, and
we are proud to bring PALFORZIA to patients in the EU who, until
now, have not had an approved therapeutic option,” said Andrew
Oxtoby, President and CEO of Aimmune Therapeutics. “We are grateful
for the efforts of the peanut allergy community who contributed to
the development program. Now we turn our efforts toward working
with health authorities to ensure access of this first-of-kind
treatment for those children with peanut allergy for whom our
product is appropriate as we prepare to launch in Germany and the
UK in May 2021.”
“Today’s news of the EC approval represents the first-ever
treatment option approved for peanut allergy in the EU and
underscores our vision of providing end-to-end solutions as a
driver of wellness and treatment, including prescription medicines
for food allergy,” said Greg Behar, CEO of Nestlé Health
Science.
Food allergies affect around 17 million people across Europe.1
Peanut allergy is one of the most common food allergies in Europe,
with the prevalence doubling among children between 2005 and
2015.1,2,3 The incidence of hospital admissions due to severe
allergic reactions also increased seven-fold, and around two-thirds
of schools in Europe have at least one child at risk of
anaphylaxis.1 Analyses in multiple European countries estimate that
around 1.6% of European children live with peanut allergy, with
estimations ranging from 0.24% to 2% depending on the diagnostic
methods used.4 Severe reactions, which can be life threatening, and
the difficulty of avoidance create an urgent need for
treatment.5
“Results from landmark Phase 3 clinical trials have shown more
than half of patients treated with PALFORZIA were able to tolerate
the equivalent of seven to eight peanut kernels after up to nine
months of treatment. These compelling data highlight its potential
to mitigate against severe allergic reactions, including
anaphylaxis in the event of unintended exposure to peanut protein,”
said Prof. George du Toit, M.B., B.Ch., Professor of Paediatric
Allergy at Evelina London Children’s Hospital, Guy's and St Thomas'
NHS Foundation Trust, King’s College London and study investigator
for the PALISADE and ARTEMIS trials. “Today’s announcement is a
very important step and means that we are closer than ever before
to being able to provide an approved treatment for patients with
peanut allergy.”
The approval was based on a package of data including two
pivotal Phase 3 clinical trials, PALISADE and ARTEMIS.6,7,8 In both
studies, PALFORZIA treatment resulted in a significant increase in
the amount of peanut protein tolerated, compared to placebo.7
“The incidence of peanut allergy has been increasing across
Europe and the threat of accidental exposure is an everyday reality
for people with peanut allergy as avoidance is difficult. As a
result, many patients and their families suffer a daily toll of
uncertainty, stress and fear of a severe reaction,” said Sabine
Schnadt, food allergy and anaphylaxis expert at Deutscher Allergie
und Asthmabund e.V. (DAAB), a German allergy advocacy organization.
“A treatment option which provides an additional level of
protection has long been awaited in the peanut allergy community
and so we are thrilled with today’s news.”
About PALFORZIA
PALFORZIA is a complex biologic drug used with a structured
dosing approach that builds on a century of oral immunotherapy
(OIT) research. With OIT, the specific allergenic proteins are
ingested initially in very small quantities, followed by
incrementally increasing amounts, that can result in the ability to
mitigate allergic reactions to the allergen over time. PALFORZIA is
a rigorously developed, pharmaceutical-grade OIT for peanut allergy
with a well-defined allergen profile to assure the consistency of
every dose, from 0.5 mg (equivalent to 1/600th of a peanut) to 300
mg.
PALFORZIA is not intended for, and does not provide, immediate
relief of allergic symptoms. Therefore, this medicinal product is
not to be used for emergency treatment of allergic reactions,
including anaphylaxis. Self-injectable adrenaline (epinephrine)
must be available to the patient at all times.
About the PALISADE and ARTEMIS Phase 3 Clinical
Trials
PALISADE (Peanut Allergy Oral Immunotherapy Study of AR101 for
Desensitization) and ARTEMIS (AR101 Trial in Europe Measuring Oral
Immunotherapy Success) evaluated the efficacy and safety of
PALFORZIA in 671 participants aged 4 to 17 with peanut allergy in
North America and Europe.
Participants enrolled represented a highly allergic population
with a high prevalence of comorbidities who reacted to low doses of
peanut protein at the screening double-blind, placebo-controlled
food challenge (DBPCFC). Participants underwent an initial dose
escalation period for 20 to 40 weeks starting at 3 mg until the 300
mg dose was reached. Participants then underwent six months
(PALISADE) or three months (ARTEMIS) of maintenance immunotherapy
with 300 mg PALFORZIA or placebo until the end of the study.
The primary efficacy endpoint in both studies was the proportion
of participants who tolerated a single highest dose of at least
1,000 mg peanut protein (equivalent to seven peanut kernels
cumulatively) with no more than mild allergic symptoms at the exit
challenge. Key secondary endpoints included desensitization
response rates after single doses of 300 mg and 600 mg peanut
protein and the maximum severity of symptoms at the exit
challenge.7
Endpoint
PALISADE
ARTEMIS
PALFORZIA
n=372
Placebo
n=124
PALFORZIA
n=132
Placebo
n=43
Proportion of participants who tolerated
1,000 mg peanut protein (95% CI; P-value < 0.0001)
50.3%
(45.2, 55.3)
2.4%
(0.8, 6.9)
58.3%
(49.4, 66.8)
2.3%
(0.1, 12.3)
Proportion of participants who tolerated
600 mg peanut protein (95% CI; P-value < 0.0001)
67.2%
(62.3, 71.8)
4.0%
(1.7, 9.1)
68.2%
(59.5, 76.0)
9.3%
(2.6, 22.1)
Proportion of participants who tolerated
300 mg peanut protein (95% CI; P-value < 0.0001)
76.6%
(72.1, 80.6)
8.1%
(4.4, 14.2)
73.5%
(65.1, 80.8)
16.3%
(6.8, 30.7)
The safety profile was as expected for an oral desensitization
therapy. The most common adverse reactions (of any severity) were
abdominal pain (49.4%), throat irritation (40.7%), pruritus
(33.7%), nausea (33.2%), vomiting (28.5%), urticaria (28.5%), oral
pruritus (26.0%), abdominal discomfort (22.9%), and abdominal pain
upper (22.8%).7
About Aimmune
Aimmune Therapeutics, Inc., a Nestlé Health Science Company, is
a biopharmaceutical company developing and commercializing
treatments for potentially life-threatening food allergies and
other food-mediated conditions, including gastrointestinal
conditions. Aimmune Therapeutics has one FDA- and EU-approved
medicine for peanut allergy and other investigational therapies in
development. For more information, please visit
www.aimmune.co.uk.
About Nestlé Health Science
Nestlé Health Science (NHSc), a wholly owned subsidiary of
Nestlé, is a globally recognized leader in the field of nutritional
science. At NHSc we are committed to empowering healthier lives
through nutrition for consumers, patients and their healthcare
partners. We offer an extensive consumer health portfolio of
industry-leading medical nutrition, consumer and vitamins, minerals
and supplements (VMS) brands that are science-based solutions
covering all facets of health from prevention, to maintenance, all
the way through to treatment. NHSc is redefining the way we
approach the management of health in several key areas such as
pediatric health, allergy, acute care, oncology, metabolic health,
healthy aging, gastrointestinal health, and inborn errors of
metabolism. Headquartered in Switzerland, NHSc employs over 5,000
people around the world who are committed to making a difference in
people's lives, for a healthier today and tomorrow.
www.nestlehealthscience.com.
1 EAACI. Food Allergy & Anaphylaxis Public Declaration,
2015. Available at:
http://dgaki.de/wp-content/uploads/2014/04/FoodAllergyAnaphylaxisPublicDeclarationCombined.pdf.
Accessed: 13 Nov 2020
2 Du Toit G, et al. Randomized Trial of Peanut Consumption in
Infants at Risk for Peanut Allergy. N Engl J Med 2015; 372:
803-13
3 Worldallergy.org. 2019. Food Allergy World Allergy
Organization. Available at:
https://www.worldallergy.org/education-and-programs/education/allergic-disease-resource-center/professionals/food-allergy
4 Nwaru BI, et al. The epidemiology of food allergy in Europe: a
systematic review and meta-analysis. Allergy 2014; 69: 62–75.
5 Bock SA, Muñoz-Furlong A, Sampson HA. Fatalities due to
anaphylactic reactions to foods. J Allergy Clin Immunol.
2001;107:191-3.
6 PALFORZIA. Summary of Product Characteristics.
7 Vickery BP, et al. AR101 oral immunotherapy for peanut
allergy. New Engl J Med 2018; DOI: 10.1056/NEJMoa1812856
8 Hourihane JO, et al. Efficacy and safety of oral immunotherapy
with AR101 in European children with a peanut allergy (ARTEMIS): a
multicentre, double-blind, randomised, placebo-controlled phase 3
trial. Lancet Child & Adolescent Health. 2020; 4:10:
728-739.
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version on businesswire.com: https://www.businesswire.com/news/home/20201220005027/en/
Global: Jodi Sievers +1 (628) 250-6849 jsievers@aimmune.com
Europe: Sophie Shey +44 7964 560008 sshey@w2ogroup.com
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